drugset / Trial / NCT01626118

Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

NCT01626118 ↗

Phase 3 Completed 373 enrolled Iroko Pharmaceuticals, LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.

Timeline

Start
2012-05
Primary completion
2012-08
Completion
2012-08

Outcome

Met primary endpoint

registry Indomethacin 40 mg TID vs Placebo; p <0.001; Difference in Least Squares Mean 503.008 (95% CI 301.930 to 704.086); Mixed Models Analysis NCT01626118 ↗

registry Indomethacin 40 mg BID vs Placebo; p <0.001; Difference in Least Squares Mean 511.357 (95% CI 309.749 to 712.965); Mixed Models Analysis NCT01626118 ↗

registry Indomethacin 20 mg TID vs Placebo; p <0.001; Difference in Least Squares Mean 341.232 (95% CI 139.249 to 543.215); Mixed Models Analysis NCT01626118 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Indomethacin Small molecule 20 mg —
Subject Indomethacin Small molecule 40 mg —

Indications

No indication recorded.